A	B	C	D
1	Main
2		Brand Name	Nucynta, fka R331333
3		Generic Name	Tapentadol
4		Indication	Chronic Pain
5		Administration	Oral
6		Mechanism	Mu-receptor agonist and norepinephine reuptake inhibitor.
7		Economics	USA, Canada, Japan licensed from Gruenethal
8		Timeline	10/31/11: Files NDA for Nucynta ER for DPNP.
9			8/26/2011: FDA approves Nucynta ER.
10		Clinical Trials
11			7 Trials at APS
12			Phase III - Presented at APS meeting 2008
13			n=659 vs oxycodone vs placebo, similar efficacy to oxycodone. Side effects - oxy 26% constipation vs 4%-7% tapentadol (50-75mg).
14			Side Effects	Constipation - oxy 26%, tapentadol 4-7% (50-75mg)
15				Nausea - oxy 41%, tapentadol 18-21%
16				Vomiting - oxy 31%, tapentadol 7-14%
17			n=603, placebo controlled, randomized tapentadol (50,75,100mg), oxycodone 15mg or placebo
18				Primary endpoint was sum of pain intensity differences 48hrs post treatment, secondary at 12, 24, 72 hrs
19				All three tapentadol arms had statistically significant pain improvement vs placebo and lower GI side effects that oxycodone
20
21		How much does oxycodone / oxycontin sell?
22		Find more info on Gruenethal